NCT04378868

Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.

Conditions

• Appendicitis

Interventions

Type	Name	Description
DRUG	Antibiotics, cefuroxime and metronidazole	Patient receives antibiotics while waiting appendectomy
DRUG	No antibiotics	No antibiotics are given while waiting surgery.
OTHER	urgent schedule	Patients can wait up to 8 hours for surgery.
OTHER	less urgent schedule	Patients can wait up to 24 hours for surgery.

Timeline

• Start date: 2020-05-18
• Primary completion: 2023-01-23
• Completion: 2023-02-23
• First posted: 2020-05-07
• Last updated: 2023-07-11

Locations

2 sites across 1 country: Finland